Gastrointestinal CancerMA-PPINGNCT04189393
Microbiome Analysis in esoPhageal, PancreatIc and Colorectal CaNcer Patients Undergoing Gastrointestinal Surgery
An observational study of Gastrointestinal Cancer and Colorectal Cancer, run by Radboud University Medical Center.
Trial summary
The MA-PPING is a multicenter prospective observational study that includes patients undergoing surgery for gastrointestinal cancer. The study aims to map the oral and gut microbiome of patients diagnosed with pancreatic, esophageal or colorectal cancer during their surgical patient journey from the moment of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer, Colorectal Cancer, Pancreatic Cancer
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients who are presented/present at the participating hospitals with a proven gastrointestinal malignancy and scheduled for surgery.
Who may be able to join
- Patients with proven malignancy of the distal esophagus, pancreatic head/corpus, colon or rectum
- Patients undergoing primary elective surgery with construction of an anastomosis of the gastrointestinal tract
- Adult patients above age 18 years
- Written informed consent
Who cannot join
- History of chronic gastro-intestinal disease e.g. Crohns disease and ulcerative colitis
- Presence of acute gastrointestinal infection
- Chronic use of oral antibiotics (3 months or longer)
- Patients undergoing gastrointestinal surgery for gastrointestinal cancer in acute setting
- Patients undergoing construction of an end/loop colostomy or ileostomy (following primary resection)
- Patients undergoing colon and/ or rectal resection without construction of an anastomosis
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- Patients who have insufficient knowledge of the Dutch language
- Patients who are not able to give reliable answers to the questionnaires due to a (mental) disease or (cognitive) condition
- Patients who are not able to collect microbiome samples due to a physical or mental condition
Trial locations and contacts
No sites are listed yet.
About this study
The MA-PPING is a multicenter prospective observational study that includes patients undergoing surgery for gastrointestinal cancer.
The study aims to map the oral and gut microbiome of patients diagnosed with pancreatic, esophageal or colorectal cancer during their surgical patient journey from the moment of diagnosis until full recovery (three months after surgery).
Read the detailed description
Rationale: The gut microbiome is the composition of micro-organisms that reside in the gastrointestinal tract. Under normal circumstances, the microbiome is balanced and has a beneficial effect on gut function. However, when the microbiome is stressed i.e. by an operation, patients' health or medication, the composition of the microbiome may change rapidly and the virulence of its micro-organisms can increase fast. Surgery, in particular gastrointestinal surgery, has a disruptive effect on the mucosal gut barrier and may lead to shifts in microbial composition. Also, the underlying surgical disease itself can be characterized by changes in the microbiome. Gastrointestinal cancer is associated with specified alterations of the microbiome, and the presence of certain microbiota is related with carcinogenesis and lymph node involvement.
Anastomotic leakage is a severe complication after gastrointestinal surgery and several animal studies linked microbial shifts to the development of anastomotic leakage. Only a few, small and explorative, human studies investigated the microbiome during surgery and correlated their findings with the development of postoperative complications. However, the majority of these studies only sampled the microbiome intraoperatively. Surgery-related microbial shifts manifest also in the pre- and postoperative phase, therefore, sampling in these phases is crucial. To further understand the changes of the microbiome composition due to gastrointestinal surgery and the relation with postoperative infectious complications, samples should be collected on several time points; before, during, and after surgery. With this study we aim to map the oral and gut microbiome of patients diagnosed with pancreatic, esophageal or colorectal cancer in a time frame ranging from the work-up for an operation until the postoperative phase to assess the changing composition of the microbiome during a surgical patient journey.
- Conditions
- Gastrointestinal Cancer, Colorectal Cancer, Pancreatic Cancer, Esophageal Cancer, Rectum Neoplasm, Esophageal Neoplasms
- Medical subject headings
- Gastrointestinal Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Esophageal Neoplasms, Rectal Neoplasms, Colonic Neoplasms, Anastomotic Leak
What is being measured
The primary outcome is the main question the study is designed to answer.
Compositional changes of the oral and gut microbiome, assessed by alpha-diversity using 16S rRNA (ribosomal ribonucleic acid) sequencing, described in a surgical patient journey from moment of diagnosis until full recovery
Changes of the microbiome composition during the surgical treatment quantified as alpha-diversity by 16S rRNA sequencing. Samples will be collected on 7 moments, starting one month before surgery until three months after surgery.
Measured: 4 months
Secondary outcomes (5)
Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with neo-adjuvant therapy
The effect of neo-adjuvant therapy on microbiome composition quantified as beta-diversity by 16S rRNA sequencing
Measured: 1 month
Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with antibiotic prophylaxis
The effect of (preoperative) antibiotic prophylaxis on microbiome composition quantified as beta-diversity by 16S rRNA sequencing
Measured: 1 week
Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with bowel preparation
The effect of preoperative bowel preparation on microbiome composition quantified as beta-diversity by 16S rRNA sequencing
Measured: 1 week
Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with selective decontamination of the digestive tract (SDD)
The effect of selective decontamination of the digestive tract (SDD) on microbiome composition quantified as beta-diversity by 16S rRNA sequencing
Measured: 1 week
Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated to the development of infectious complications (30-day)
The effect of infectious complications (such as anastomotic leakage, sepsis, wound infection, pneumonia and urinary tract infection) on microbiome composition quantified as beta-diversity by 16S rRNA sequencing
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan AW Bouwense, MD PhD, Principal investigator, Radboud University Medical Center NijmegenMartijn WJ Stommel, MD PhD, Principal investigator, Radboud University Medical Center NijmegenHarry van Goor, MD PhD, Principal investigator, Radboud University Medical Center Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189393
- Sponsor's protocol ID
- 2019-5859
- Acronym
- MA-PPING
- Status last verified
- Nov 2019
- First submitted
- 25 Nov 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome Analysis in esoPhageal, PancreatIc and Colorectal CaNcer Patients Undergoing Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT04189393
- Acronym / sponsor ID
- MA-PPING / 2019-5859
- Conditions
- Gastrointestinal Cancer, Colorectal Cancer, Pancreatic Cancer, Esophageal Cancer, Rectum Neoplasm, Esophageal Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The MA-PPING is a multicenter prospective observational study that includes patients undergoing surgery for gastrointestinal cancer.
The study aims to map the oral and gut microbiome of patients diagnosed with pancreatic, esophageal or colorectal cancer during their surgical patient journey from the moment of diagnosis until full recovery (three months after surgery).
Detailed description
Rationale: The gut microbiome is the composition of micro-organisms that reside in the gastrointestinal tract. Under normal circumstances, the microbiome is balanced and has a beneficial effect on gut function. However, when the microbiome is stressed i.e. by an operation, patients' health or medication, the composition of the microbiome may change rapidly and the virulence of its micro-organisms can increase fast. Surgery, in particular gastrointestinal surgery, has a disruptive effect on the mucosal gut barrier and may lead to shifts in microbial composition. Also, the underlying surgical disease itself can be characterized by changes in the microbiome. Gastrointestinal cancer is associated with specified alterations of the microbiome, and the presence of certain microbiota is related with carcinogenesis and lymph node involvement.
Anastomotic leakage is a severe complication after gastrointestinal surgery and several animal studies linked microbial shifts to the development of anastomotic leakage. Only a few, small and explorative, human studies investigated the microbiome during surgery and correlated their findings with the development of postoperative complications. However, the majority of these studies only sampled the microbiome intraoperatively. Surgery-related microbial shifts manifest also in the pre- and postoperative phase, therefore, sampling in these phases is crucial. To further understand the changes of the microbiome composition due to gastrointestinal surgery and the relation with postoperative infectious complications, samples should be collected on several time points; before, during, and after surgery. With this study we aim to map the oral and gut microbiome of patients diagnosed with pancreatic, esophageal or colorectal cancer in a time frame ranging from the work-up for an operation until the postoperative phase to assess the changing composition of the microbiome during a surgical patient journey.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients who are presented/present at the participating hospitals with a proven gastrointestinal malignancy and scheduled for surgery.
Key inclusion criteria (4 listed)
- Patients with proven malignancy of the distal esophagus, pancreatic head/corpus, colon or rectum
- Patients undergoing primary elective surgery with construction of an anastomosis of the gastrointestinal tract
- Adult patients above age 18 years
- Written informed consent
Key exclusion criteria (9 listed)
- History of chronic gastro-intestinal disease e.g. Crohns disease and ulcerative colitis
- Presence of acute gastrointestinal infection
- Chronic use of oral antibiotics (3 months or longer)
- Patients undergoing gastrointestinal surgery for gastrointestinal cancer in acute setting
- Patients undergoing construction of an end/loop colostomy or ileostomy (following primary resection)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compositional changes of the oral and gut microbiome, assessed by alpha-diversity using 16S rRNA (ribosomal ribonucleic acid) sequencing, described in a surgical patient journey from moment of diagnosis until full recovery
Time frame: 4 months
Changes of the microbiome composition during the surgical treatment quantified as alpha-diversity by 16S rRNA sequencing. Samples will be collected on 7 moments, starting one month before surgery until three months after surgery.
5 secondary outcomes
Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with neo-adjuvant therapy
Time frame: 1 month
Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with antibiotic prophylaxis
Time frame: 1 week
Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with bowel preparation
Time frame: 1 week
Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with selective decontamination of the digestive tract (SDD)
Time frame: 1 week
Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated to the development of infectious complications (30-day)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan AW Bouwense, MD PhD principal investigator
Radboud University Medical Center Nijmegen
Martijn WJ Stommel, MD PhD principal investigator
Radboud University Medical Center Nijmegen
Harry van Goor, MD PhD principal investigator
Radboud University Medical Center Nijmegen
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Cancer and Colorectal Cancer, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melissa NN Arron, MD (+31243613983, melissa.arron@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compositional changes of the oral and gut microbiome, assessed by alpha-diversity using 16S rRNA (ribosomal ribonucleic acid) sequencing, described in a surgical patient journey from moment of diagnosis until full recovery (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.